Surgical Removal of Prostate Tumor and Antiandrogen Therapy with or without Docetaxel in Treating Men with Newly Diagnosed Metastatic Prostate Cancer

Status: Active

Description

This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Histologically proven adenocarcinoma of the prostate
  • Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
  • Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis)
  • If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)
  • No previous local therapy for prostate cancer
  • Give informed consent
  • Prostate deemed resectable by surgeon
  • Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Hemoglobin (HgB) >= 9 g/dL compatible for surgery
  • Platelets > 80,000 compatible for surgery
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN) compatible for surgery

Exclusion Criteria

  • Refuses to give informed consent
  • Deemed to have unresectable disease by surgeon
  • Received ADT for more than 6 months prior to randomization
  • Life expectancy of less than 6 months prior to randomization
  • Known spinal cord compression
  • M1c disease (solid organ metastasis)
  • Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months prior to randomization
  • Previous local therapy for prostate cancer
  • Previous chemotherapy for prostate cancer
  • Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier
  • Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Bertram Emmanuel Yuh
Phone: 626-218-5733
Email: byuh@coh.org
Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Monish Aron
Phone: 323-865-3700
Email: monish.aron@med.usc.edu
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Thomas Edward Ahlering
Phone: 714-456-6068
Email: tahlerin@uci.edu

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Scott E. Eggener
Phone: 773-702-1860
Email: seggener@surgery.bsd.uchicago.edu

Kentucky

Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: Active
Contact: Ahmed Haddad
Phone: 502-588-4740
Email: ahmed.haddad@louisville.edu

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Isaac Yi Kim
Phone: 732-235-2043
Email: kimiy@cinj.rutgers.edu

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Approved
Contact: Edouard John Trabulsi
Phone: 215-955-1000
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: David Lee
Email: david.lee@uphs.upenn.edu

Washington

Seattle
Swedish Medical Center-Cherry Hill
Status: Active
Contact: James R. Porter
Phone: 206-386-6266
Email: porter@swedishurology.com

China

Shatin
Chinese University of Hong Kong-Prince of Wales Hospital
Status: Active
Contact: Chi Fai Ng
Phone: 852-3505-2625
Email: ngcf@surgery.cuhk.edu.hk

Japan

Osaka
Kindai University
Status: Active
Contact: Hirotsugu Uemura
Phone: 81 723660221
Email: huemura@med.kindai.ac.jp

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the clinical benefit of combining radical surgery – cytoreductive radical prostatectomy (CRP) - with the best systemic therapy (BST) in men with newly diagnosed clinical M1a or M1b metastatic prostate cancer (mPCa).

SECONDARY OBJECTIVES:

I. To determine the impact of CRP+BST on time to biochemical progression, cancer-specific survival, complication rates, and quality of life (QOL) in patients with mPCa.

II. To determine the transcription levels of bone morphogenetic protein -6 (BMP-6) and transforming growth factor-beta (TGF-beta).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive antiandrogen therapy with or without docetaxel at the discretion of the treating physician.

ARM II: Participants receive antiandrogen therapy for at least 1 month, then undergo cytoreductive radical prostatectomy. Participants continue antiandrogen therapy and may receive docetaxel within 3 months after surgery at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 6 months from time of progression.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Rutgers Cancer Institute of New Jersey

Principal Investigator
Isaac Yi Kim

Trial IDs

Primary ID 081707
Secondary IDs NCI-2018-00047
Clinicaltrials.gov ID NCT03456843